Mentor Requirements:

Student Requirements:

Pharmacists to sign-up as a mentor: Mentoring Application

Congratulations to our student chapters who were recently recognized by ASHP.

VSHP Leadership Profile
Lindsay Enzor

 

What is your current leadership position in VSHP?

Region 5 President-elect

 

What benefits do you see in being active in a professional association such as VCHP?  

 

What initially motivated you to get involved in VCHP?

My boss recommended me getting involved to have networking and to help push the field of pharmacy farther.  

 

Where did you go to pharmacy school?

VCU  

 

Where have you trained or worked?  

Riverside Health System  

 

Describe your current area of practice and practice setting:

Pharmacy administration - pharmacy director  

 

What advice would you give to student pharmacists?

I regret not being more involved in local/state organizations during pharmacy school. I think it would have better prepared me for much needed networking social skills. It also introduces you to a lot of top leaders in the field that would be an asset later down the road.

 

What pharmacy related issues keep you up at night?

340B, continuum of care, trying to balance all my priorities along with keeping up with what is going on with pharmacy

 

Do you have any special interests or hobbies outside of work?

Heavily involved in women's ministry with my church, painting/lettering, running  

 

What is your favorite place to vacation?

Florida

 

What 3 adjectives would people use to best describe you?

Passionate, animated, funny

HU-SSHP's Chapter Activities

 

Isha Jariwala

Doctor of Pharmacy Candidate 2017

Hampton University School of Pharmacy

 

A number of student activities were implemented under the leadership of 2015-2016 E-board of Hampton University Student Society of Health-System Pharmacists (HU-SSHP). Our chapter members had a variety of opportunities: learn about residency programs, compiling CVs, get connected to the mentors through the ASHP website, learn from guest speakers who came from different clinical backgrounds; attend state and national meetings, etc. In addition to the developmental activities, students were able to raise awareness in the community via various community service events. We started our year collaborating with APhA-ASP chapter of Hampton University along with the local authorities-DEA and Sheriff's office, and a major hospital in the area-to hold the National Drug Take-Back Day on September 26, 2015. Despite the weather conditions, it was a notable turnout for both the HU chapter and the public. We concluded the day with over 200 pounds of reconciled medications with many informed patients in regards to safe medication disposal. It was a huge achievement and a great impact to the community.

 

On May 4^th 2016, Hampton University's SSHP chapter organized an educational event in collaboration with the local clinic-Community Free Clinic of Newport News. The event focused on educating the patients of the clinic on common health conditions-diabetes, hypertension, hypercholesterolemia-afflicting the people of Hampton Roads Area, in addition to enlightening them on safe drug disposal and medication safety. This event was the highlight of the year's community service events as we reached out to a vast number of patients, talked to them about their respective health conditions, and counseled them about their medications under the supervision of Dr. Francis Ndemo, Associate Professor at Hampton University School of Pharmacy. One-on-one interactions with the patients helped us not only to apply the knowledge that we had obtained thus far, but also bring welfare to the community.

 

Furthermore, presentations on "Immunizations-What you should know and why you still need them!" were presented to the seniors of both a local senior center and a church on two separate occasions. The presentations gave us a sense of accomplishment as they both were followed by a series of questions from the curious audiences to learn more about immunizations.

 

On the whole, the 2015-16 year brought to our chapter members and myself a lot of learning experiences. Personally, it was an honor to not just serve the community, but also learn while serving the community.

 

New Drug Update: Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide)

 

Cindy Cheng, PharmD Candidate 2017, and Leigh Hylton Gravatt, PharmD, BCPS; Virginia Commonwealth University Health System

 

Approved by the FDA in March 2016, Odefsey® is the smallest pill of any single-tablet, once-daily complete regimen for the initial treatment of HIV-1.1 Initial antiretroviral therapy for treatment-naïve patients generally consists of two nucleoside analog reverse transcriptase inhibitors (NRTIs) with either an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a pharmacokinetic-enhanced protease inhibitor (PK-enhanced PI).2 Odefsey® contains two NRTIs, emtricitabine (FTC) and tenofovir alafenamide (TAF), and an NNRTI, rilpivirine (RPV). Odefsey®, the newer version of Complera® (FTC 200 mg/RPV 25 mg/TDF 300 mg), is formulated with tenofovir alafenamide (TAF) instead of tenofovir disoproxil fumarate (TDF), and it is the second TAF-based regimen to be approved by the FDA.1

 

Indication and Usage

Odefsey® is indicated for the initial treatment of HIV-1 infection in patients aged 12 and older with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL. It is also indicated to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey®. It is available as a fixed-dose tablet containing 200 mg FTC, 25 mg RPV, and 25 mg TAF, and the recommended dose is one tablet by mouth once daily with a meal. Due to the rilpivirine component, it has been shown to have higher concentrations when administered with a high fat meal, and concentrations can be decreased up to 40% in a fasting state and decreased by 50% when co-administered with a protein shake versus a meal (regular or high fat). Odefsey® should not be used in patients with severe renal impairment (creatinine clearance less than 30 mL/min).3 There are no dosage adjustments recommended in mild or moderate hepatic impairment (Child-Pugh Class A or B), but it has not been studied in individuals with severe hepatic impairment.

 

Clinical Pharmacology of TAF

Tenofovir disoproxil fumarate, which has been a mainstay in HIV therapy, is a pro-drug that is converted to the active metabolite tenofovir disphosphate in the blood. After entering the cell, tenofovir disphosphate works by incorporating itself, an adenosine nucleotide analog, into viral DNA, subsequently causing termination of the viral DNA chain and inhibition of HIV-1 replication. Tenofovir alafenamide is a novel targeted pro-drug of tenofovir that features similar efficacy in viral load suppression compared to TDF, but at less than one-tenth of the dose of TDF since TAF enters cells more efficiently due to its increased stability in plasma and intracellular conversion to tenofovir disphosphate.3,4 Comparing TAF 25 mg with TDF 300 mg, use of TAF yields 86% less serum drug concentration than TDF. Despite the lower dose of TAF, TAF administration resulted in a seven-fold increase in tenofovir diphosphate in peripheral blood mononuclear cells and increased distribution of tenofovir into lymphatic tissue. Unlike TDF, TAF does not enter proximal tubule cells through organic anion transporters OAT1 and OAT3, so there is less accumulation in the kidneys. In Phase III clinical trials, there were no discontinuation of either TAF or TDF due to renal toxicity, however, there was a statistically significant difference in the change of baseline serum creatinine at week 48 (TAF: -0.08 mg/dL vs.TDF: -0.04 mg/dL), higher increases in the GFR in the TAF group (TAF: 8.4 ml/min vs. TDF: 2.8 ml/min), and decreased incidence of proteinuria in the TAF group (TAF: -15% vs. TDP: 8%). 4.1 Thus, use of TAF leads to better tolerability and less side effects, such as a lower risk of renal toxicity and decreased bone mineral density (BMD).4

 

Clinical Studies

Approval of Odefsey® was based on bioequivalence in achieving similar drug levels of FTC and TAF in Genvoya® (elvitegravir 150 mg/cobistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, or E/C/F/TAF), the first FDA-approved TAF-based regimen, and Edurant (RPV 25 mg) under fed conditions. The presence of cobicistat, a pharmacoenhancer, accounts for the difference in quantity of TAF between the formulations of Odefsey® and Genvoya® (TAF 25 mg vs. 10 mg).6 E/C/F/TAF had previously proven bioequivalence to Stribild (E/C/F/TDF) at weeks 24 and 48 with significantly less renal tubular dysfunction, less decrease in BMD for the spine and hip, and more evidence of no decrease in BMD for the spine and hip.4 The safety, efficacy, and tolerability of Odefsey® are further supported by findings from other clinical studies.

(1)    One study demonstrated that RPV+FTC/TDF caused high virologic response rates as initial HIV-1 therapy and greater virologic response in patients with baseline HIV-1 RNA less than or equal to 100,000 copies per mL and also in patients with baseline CD4+ cell counts greater than or equal to 200 cells/mm3.3

(2)    RPV/FTC/TAF was found to be efficacious in patients ages 12-18 years old and greater than 32-35 kg as initial therapy in those without prior antiretroviral therapy (ART) and as replacement of a stable ART regimen in virologically-suppressed patients.3

(3)    Safety in non-severe renal impairment was supported by a study demonstrating virological suppression achieved with FTC+TAF and EVG+COBI in 95% of HIV-1 infected adults with creatinine clearance between 30-70 mL/min.3

(4)    In a Phase 3 study comparing E/C/F/TDF to E/C/F/TAF, at 48 weeks, there was a significantly less renal impairment (greater decrease in creatinine clearance, -6.4 vs. -11.2 mL/min), less proteinuria (change from baseline urinary protein to creatinine, -5% vs. 7%), and less renal tubular damage (change from baseline retinol-binding protein to creatinine, 9% vs. 51%; change from baseline urine β-2 microglobulin to creatinine, −32% vs 4%). There was also a greater decrease in BMD of the spine (−1.3% vs 2.86%), BMD of the hip (−0.66% vs −2.95%).4

(5)    In addition, recently completed Phase 3b studies directly comparing Odefsey® to TDF-based regimens revealed a similar rate in virologic suppression at week 48 compared to Complera® (FTC 200 mg/RPV 25 mg/TDF 300 mg) and Atripla® (efavirenz 600 mg/FTC 200 mg/TDF 300 mg) and demonstrated statistically significant improvements in BMD at the hip and spine and in total and tubular proteinuria compared to both regimens.7

 

Contraindications and Significant Drug Interactions

Odefsey® is contraindicated when using drugs that cause significant decreases in RPV plasma concentrations, which includes interactions with strong CYP3A4 inducers (i.e., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort, more than one dose of dexamethasone) and drugs that increase gastric pH (i.e., PPIs, H2 antagonists). Significant decreases in RPV plasma concentrations may lead to loss of efficacy and resistance to NNRTIs. Other drug interactions include strong CYP3A4 inhibitors (i.e., tipranavir, clarithromycin) that increase serum RPV concentrations and increase adverse effects, strong involvement of P-glycoprotein (P-gp) (i.e., cyclosporine), which can decrease TAF absorption, and drugs that affect active tubular secretion (i.e., acyclovir, aminoglycosides).3,8

 

Adverse Reactions

The most common adverse effects are depressive disorders, insomnia, and headache (≥2%, associated with RPV) and also nausea (≥10%, associated with FTC and TAF). Other warnings for Odefsey® include severe skin and hypersensitivity reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Torsade de Points with concomitant use of drugs that prolong the QTc interval, redistribution/accumulation of body fat, immune reconstitution syndrome, new onset or worsening renal impairment, and bone loss and mineralization defects. Odefsey® has the boxed warnings of lactic acidosis and severe hepatomegaly with steatosis associated with use of NRTIs, as well as acute exacerbations of hepatitis B in patients who are co-infected with HIV-1 and hepatitis B virus (HBV) infection associated with use of emtricitabine and/or TDF. Therefore, Odefsey® should not be used in severe renal impairment (creatinine clearance less than 30 mL/min) or for treatment of chronic HBV infection, and patients should be tested for HBV prior to initiation of this drug.3,8 It is recommended to monitor hepatic function closely for several months if patients are coinfected with HIV-1 and HBV.3

 

Place in Therapy

The US Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents currently recommends six regimens for treatment-naïve patients, one containing TAF (Genvoya) and four containing TDF or its TAF-equivalent with use of the recently FDA-approved Descovy® (FTC/TAF). DHHS recommends Odefsey® as an alternative initial regimen for treatment-naïve patients aged 12 and older (and at least 35 kg) if the HIV RNA is less than 100,000 copies/mL and a CD4+ greater than 200 cells/mm3.2 Since research has supported that TAF has demonstrated similar efficacy and improved tolerability and safety, TAF-based regimens may become preferred over the TDF-based regimens for treatment of HIV-1 infection, especially for growing adolescents, elderly patients, and patients at risk for renal or bone disease.8

 

References